Introduction

ISO 9001:2008
TRAINING PROGRAMME
on
QUALITY MANAGEMENT SYSTEM
for
TOP MANAGEMENT
SAMTEL MACHINES, GHAZIABAD
5 OCT, 2010
CONCEPT OF INSPECTION
ACCEPT
MANUFACTURE INSPECT
REJECT
RECTIFY
QUALITY CONCEPT
DEVELOPMENTS
INSPECTION
QUALITY CONTROL
QUALITY ASSURANCE
QUALITY SYSTEM
TQM
QUALITY AWARDS
“Quality is never an accident,
It is always the result of an

intelligent effort”
- John Ruskin
NEW THINKING ABOUT QUALITY
OLD QUALITY IS NEW QUALITY IS
 About Product  About Organizations
 Technical  Strategic
 For Inspectors  For Everyone
 Led by Experts  Led by Management
 High Grade  Appropriate Grade
 About Control  About Improvement
 Little ‘q’  BIG ‘Q’
QUALITY CHAIN
Q EXTERNAL CUSTOMER
Q SUPPLIER / CUSTOMER
Q EXTERNAL SUPPLIER
International Organization
for Standardization
www.iso.org
BACKGROUND
 ISO
 International Organization for
Standardization
 Federation of National Standards Bodies
 Head quarters at Geneva
 Formulates standards at international level
 BIS- NSB of India- member of ISO

HISTORICAL BACKGROUND OF ISO
9000 SERIES
 MIL 9858 (USA)
 AQAP 1, 4, 9 (NATO)
 DEF STD (UK)
 BS 5750 ( 6 Parts )
 ISO 9000 : 1987 (Series or Family)
 First Revision in 1994
 Second Revision in 2000
 ISO 9000 (Only, not full series) further revised

in 2005, ISO 9001 in 2008 and ISO 9004 in
2009
MEET EXISTING FAMILY OF
ISO 9000 STANDARDS
 ISO 9000:2005 QMS - Fundamentals
and Vocabulary
 ISO 9001:2008 QMS - Requirements
 ISO 9004:2009 Managing Sustained Success-
QMS Approach
 ISO 19011:2002 Guidelines for
Quality and / or Environmental Management
Systems Auditing
These Standards have been adopted by all member
countries of ISO
CHARACTERISTICS OF
QMS STANDARDS
 Complementary to product standards
 Basically cover good Quality Management
Practices
 Orderly Systematic Approach
 Generic Applicable to all types of
activities, including Services
 Flexible in approach
 Documented ( to the extent required /
stipulated )
BENEFITS
 System helps fight our enemies within:
 Lethargy
 Adhocism
 Low motivation - internal politics
 Lack of enterprise
 Lack of training
 Ineffective communication
 Poor commitment
QUALITY MANAGEMENT
PRINCIPLES
 CUSTOMER FOCUS
 LEADERSHIP
 INVOLVEMENT OF PEOPLE
 PROCESS APPROACH
 SYSTEM APPROACH TO MANAGEMENT
 CONTINUAL IMPROVEMENT
 FACTUAL APPROACH TO DECISION
MAKING
 MUTUALLY BENEFICIAL SUPPLIER
RELATIONSHIPS
TERMINOLOGY
 QUALITY
Degree to which a set of inherent
characteristics fulfills requirements
 QUALITY POLICY
Overall intentions and direction of an
organization related to quality as
formally expressed by top
management
TERMINOLOGY
 SYSTEM
A set of interrelated or interacting elements
 MANAGEMENT SYSTEM
System to establish policy and objectives
and to achieve those objectives
 QUALITY MANAGEMENT SYSTEM
Management system to direct and control
an organization with regard to quality
TERMINOLOGY
 CUSTOMER SATISFACTION
Customer’s perception of the degree to
which the customer’s requirements
have been fulfilled
 Customer complaints are a common
indicator of low customer satisfaction but
their absence does not necessarily imply
high customer satisfaction
 Even when customer requirements have
been agreed with the customer and
fulfilled, this does not necessarily ensure
high customer satisfaction
P D C A
( DEMING CYCLE)
 PLAN
 DO
 CHECK
 ACT
This concept can be applied to an
individual process or across a
group of processes
Act Plan
•How to improve •What to do?
next time? •How to do it?
Check Do
• Did things happen •Do what was
according to plan? planned
PROCERSS APPROACH
PROCESS – Any activity or a set of

activities using resources to transform
inputs to outputs
INPUT OUTPUT
PROCESS
EXAMPLE OF A PROCESS
MATERIALS
PLANT/EQUIPMENT PRODUCTS
PEOPLE
TRAINING SERVICES
SKILL PROCESS
PROCESS
KNOWLEDGE
PROCEDURES RECORDS
INFORMATION
ENERGY INFORMATION
WORK ENVIRONMENT
INPUTS OUTPUTS
NETWORK OF PROCESSES
TYPICAL PROCESSES
1. Quality Management Process,
2. Regulatory Research Process,
3. Resource Management Process,
4. Market Research Process,
5. Customer Needs Assessment Process,
6. Customer Communications Process,
7. Complaint Handling Process,
8. Customer Feedback Process,
9. Product Design Process,
10. Purchasing Process
11. Production Process
12. Equipment Maintenance Process
13. Service Provision Process
14. Product Protection Process,
15. Product Delivery Process, Post-delivery Process
TYPICAL PROCESSES (Cont.)
16. Measuring Equipment Calibration and Maintenance
17. Internal Communications Process
18. Document Control Process
19. Record Keeping Process
20. Planning Process
21. Training Process
22. Internal Audit Process
23. Management Review Process
24. Monitoring and Measuring Process
25. Nonconformity Management Process
26. Data Analysis Process
27. Continual Improvement Process –C.A. / P.A. Process
28. Computer Data Back-up Process
Some of these processes can be broken into more than one
process and vice’ versa.
CONTROLLED PROCESSES
 Controlled processes are stable processes.
 These enable you to :
 Predict results
 Enables you to prepare achievable plans
 Meet cost estimates
 Schedule commitments
 Deliver product / service quality with acceptable and
reasonable consistency.
 If not capable of meeting customer requirements
or other objectives, change or improve the
process
PROCESS APPROACH (SUMMARY)
 Identify and manage numerous
interrelated and interacting processes
 Output of one process could be input
for next process
 Manage interaction amongst processes
 Input, output and the process itself provide
opportunity for measurements, control and

continual improvement

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ISO 9001:2008

It is always the result of an

 Head quarters at Geneva

 Formulates standards at international level

 BIS- NSB of India- member of ISO

 First Revision in 1994

 Second Revision in 2000

 ISO 9000 (Only, not full series) further revised

 Low motivation - internal politics

PROCESS – Any activity or a set of

opportunity for measurements, control and

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